Quality Assurance Officer

Silva Pharmaceuticals Limited

No. of Vacancies

Job Description/Responsibilities

Documentation of QA such as issuing of BMR & BPR, compilation, product release according to production planning.

Handling of change control report, deviation report, market complaint, NCR, and out of specification.

Ensure In-process control at every step of production, Process validation and cleaning validation.

Co-ordinate with toll manufacturing company for necessary documents of Quality Assurance for finished product release.

Additional duties as assigned.

Job Nature

Full Time

Educational Requirements

Masters/ Bachelor of Pharmacy from any reputed Institution

Experience Requirements

to 1 year(s)

Additional Requirements

1 year working experience in any reputed pharmaceuticals in relevant field will be given preference

Must have the Bangladesh Pharmacy Council (BPC) Registration.

To establish procedures and specifications and then to ensure that - a) Procedures and specifications are appropriate and followed. b) Procedures and specifications under contract are also appropriate and followed, i.e. maintain control and take responsibility for third-party service providers (Contract manufacturers, contract laboratories etc).

To ensure revision and approval / rejection of any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications-including changes to these documents.

To ensure revision and approval / rejection of reprocessing and rework procedures.

To ensure revision and approval / rejection of batch records and make the final decision to release a product lot into commerce.

To conduct investigation of nonconformance and to find out and elimination of root cause for production and control record errors, discrepancies, and failure to meet specification including quality attributes and to keep management informed.

To describe responsibilities in writing which will be followed accordingly.

To monitor that there is no conflict of interest between regulatory responsibilities and actual daily activities.